Apparatus for Circumferential Suction Step Multibiopsy of the Esophagus or Other Luminal Structure with Serial Collection, Storage and Processing of Biopsy Specimens within a Removable Distal Cassette for In Situ Analysis

Abstract

A circumferential suction step multibiopsy apparatus for performing a medical procedure has an elongated flexible member with an aperture extending longitudinally therethrough and an actuator positioned within the aperture. The open tube shaft is connected to a side arm for suction or irrigation including radiopaque contrast and dye staining. There is a cassette removably connected to the actuator for cutting and serially collecting biopsy specimens, for in situ chemical, biological or genetic testing by immediate reaction with the biopsy specimens before metabolic changes, degradation or contamination can occur or for fixation, staining and other processing and analysis.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims priority from U.S. Provisional Application No. 60 / 645,896, filed on Jan. 21, 2005.BACKGROUND OF THE INVENTION[0002]1. Field of the Invention[0003]The present invention relates to an apparatus for a circumferential suction step multibiopsy of the esophagus or other luminal structure with serial collection, storage and processing of biopsy specimens in situ. The device simultaneously cuts and captures multiple circumferential suction biopsy specimens of a closely defined size to permit serial entry into a segmented removable distal storage cassette for in situ chemical, biological or genetic testing by immediate contact of reagents with the biopsy specimens before metabolic changes, degradation or contamination can occur or for fixation, staining and other processing and analysis. The cassette may be optically transparent for physical analysis of the tissue without removal from the cassette after separation from the ...

AI Technical Summary

Benefits of technology

[0017]It is therefore an object of the present invention to provide a circumferential suction step multibiopsy device with serial collection and storage of biopsy specimens in a distal removable biopsy processing cassette that is 15 to 60 French (5 mm to 30 mm) in diameter, that is simple to use and provides precise identification of the biopsy site from acquisition to histopathologic diagnosis when used with a 30 to 220 cm long flexible biopsy instrument.

[0019]For biopsy, the instrument is positioned in the lumen by depth using centimeter marks on the instrument shaft and a center line marking the anterior 12 o'clock position. To biopsy, the actuator wire is pulled to retract the blade and open the ports of the distal segment. Suction is applied through the shaft side arm, drawing the surrounding tissue into the side holes. The actuator wire is pushed, forcing the blade over the side holes and cutting the biopsies from the surrounding tissue. The number of biopsies acquired at each step is determined by the number of circumferential biopsy ports in the cassette. The proximal portion screen forces the cut biopsies into individual storage segments. Biopsy orientation, storage and processing may be facilitated by injecting fluid through the side arm.

[0021]Fluid access for processing is maintained through the shaft lumen and the screen in the proximal portion of the biopsy cassette that prevents mixing or loss of biopsies within the individual storage segments. Additionally, the distal cassette portion may be perforated to allow access of processing fluids and to peel the cassette open after processing. In this case, the perforations are covered with removable plastic to maintain suction during biopsy. Alternatively, the actuator wire may be connected to the distal biopsy segment that is biased open by an actuator wire spring within the cassette. Biopsy is then performed by applying suction and then pulling the actuator wire to move the biopsy ports over the fixed blade and cut the biopsies from the knuckle of tissue extending into the biopsy ports. After completion of the biopsy sequence, the actuator wire is locked in the closed position at the handle to maintain a closed position.

[0024]Processing for histopathology from fixation to wax embedding is performed with the biopsies in the closed storage cassette. After the biopsies are encased in wax, the storage cassette is opened. The individual storage segments with their sequential step biopsies are separated, sliced, stained and mounted for microscopy while maintaining identification of the biopsies in order of acquisition. This allows precise identification of the extent and location of abnormalities demonstrated by microscopy.

[0028]In another embodiment, the storage cassette is transparent so that the biopsies are immediately available for inspection and analysis without handling. This embodiment avoids the risk of staff exposure to fixatives or infectious agents, yet makes analysis of pristine unfixed specimens by spectroscopy or other physical methods immediately possible without contamination.

Problems solved by technology

These samples can only be retrieved by catheterization methods using endoscopic or fluoroscopic control, or by blind biopsy.

During this acquisition and collection process, the minute specimens were frequently lost and are contaminated by passage through the biopsy path or the endoscope instrument channel and by handling.

During this process, the staff is exposed to potentially infectious human fluids, tissue and toxic fixatives.

This prolonged the procedure and could cause it to fail, if the position of the biopsy instrument could not be reacquired during the repeated passes through the endoscope.

This prolongs the procedure, increasing the quantity of sedative administered to the patient, risk and cost.

Furthermore, when the extent of disease such as cancer or dysplasia required diagnosis as in Barrett's esophagus, the precise site of the biopsies was difficult to know with precision.

If after processing and microscopy, dysplasia or cancer were later identified, confirmatory biopsy or local excision was difficult as the site of positive biopsy was not well known.

Often multiple biopsy passes were required because of the limited storage capacity of the biopsy instrument and the need to identify the origin of each biopsy site.

Consequently, biopsies from different anatomic sites were handled separately, requiring considerable effort and expense.

During this complex handling process, small specimens may be lost or damaged.

At each stage of handling, the staff is exposed to toxic fixatives and infection from the biopsies.

This tedious, labor intensive process is expensive in staff required, time, equipment and laboratory space.

These specimens can be contaminated by fluid and tissue in the track traversed to obtain the biopsies and within the channel of the endoscopic instrument.

The delay in acquisition and contamination of the specimens limits the accuracy and reliability of the subsequent analysis, particularly when genetic or biological testing is required.

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